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FDA 510(k)

TRIGLYCERIDES REAGENT (PRODUCT #88218)

K-Number: K883405 · 1988-09-13

ApplicantHichem Diagnostics
Decision Date1988-09-13
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES REAGENT (PRODUCT #88218) is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K883405. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGLYCERIDES REAGENT (PRODUCT #88218)?

TRIGLYCERIDES REAGENT (PRODUCT #88218) is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Hichem Diagnostics. The 510(k) number is K883405.

When did TRIGLYCERIDES REAGENT (PRODUCT #88218) receive FDA 510(k) clearance?

TRIGLYCERIDES REAGENT (PRODUCT #88218) received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883405.

Who is the listed applicant for TRIGLYCERIDES REAGENT (PRODUCT #88218)?

The FDA 510(k) record lists Hichem Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGLYCERIDES REAGENT (PRODUCT #88218)?

The FDA product code for TRIGLYCERIDES REAGENT (PRODUCT #88218) is CDT.

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Other records listing Hichem Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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Related Devices (Code: CDT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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